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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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Companies face constant pressure to meet the increasing regulatory expectations and demands for information. Data identification through Systematic Literature Review (SLR) supports critical regulatory functions throughout the company, from MDR requirements through IND submissions.
In this session, we will review:
Learning Objectives
Upon conclusion of the program, you will be able to:
Who Should Attend?
Speaker
Laurie Mitchell is Founder and President of Criterion Edge, a global medical and regulatory writing and safety services firm serving the medical device, pharmaceutical, and biotech industries. Laurie has over 20 years of experience in medical writing, safety and pharmacovigilance management, and regulatory reporting. Having provided regulatory solutions to many pharma and medical device companies, both large and small, she is a proven leader in designing practical strategies to meet current global regulatory challenges. Laurie is a published author, and holds a Master of Nursing from UCLA.
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.